Regulatory Services Manager – National Center for Clinical Trials

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🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $44 - $66 / hour

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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Advocate Aurora Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

⚕️ Healthcare Insurance

💰 $10.2M Grant on 2019-08

Healthcare • Healthcare Insurance

Advocate Aurora Health is a leading healthcare organization that operates across various regions including Central Chicagoland, Central Wisconsin, Greater Milwaukee, and more. With a diverse range of career areas such as advanced practice clinicians, behavioral health, nursing, and more, Advocate Aurora Health is committed to helping people live well. The organization offers numerous benefits and opportunities for career advancement, fostering an environment where individuals can thrive and innovate in the healthcare sector. Advocate Aurora Health prioritizes the safety of its candidates and maintains a robust recruitment process to protect sensitive information.

📋 Description

• Provide overall administrative direction and coordination of Regulatory Services for NCCT clinical research • Ensure compliance with institutional, IRB, federal, and other applicable regulatory requirements across clinical trials • Supervise and guide staff on IRB submissions, HIPAA compliance, and regulatory communications • Develop, implement, and enforce policies, procedures, and tools supporting compliant research operations • Lead hiring, training, performance management, coaching, and professional development for regulatory staff • Oversee IRB submissions and approvals, regulatory documentation, and study closures • Ensure compliance with GCP, ICH, FDA, OHRP, HIPAA, state and federal regulations, institutional policies, and SOPs • Manage audits and inspections, including responses to findings and CAPA plans • Oversee regulatory projects and workflows, timelines, deliverables, risks, and resources • Communicate regulatory status and compliance issues to investigators, study teams, and leadership • Monitor regulatory changes and lead related process or policy updates • Support protocol development, study start-up, and close-out activities • Maintain relationships with stakeholders, sponsors, IRB, and regulatory agencies • Prepare regulatory metrics, reports, and compliance analyses • Participate in research compliance and regulatory affairs meetings and committees • Manage special regulatory projects and perform related duties

🎯 Requirements

• Master's degree in a relevant discipline such as Health Administration, Nursing, Business, or Basic Science with three years of relevant management experience; or an equivalent combination of education and experience • Experience in a medical/research environment preferred • Excellent verbal and written communication skills • Knowledge of scientific and statistical principles • Ability to travel to affiliate sites, clinical sites, and national meetings • Familiarity with institutional and governmental regulations and guidelines related to clinical research • Knowledge of Good Clinical Practices

🏖️ Benefits

• Comprehensive Total Rewards benefits and well-being programs • Competitive compensation • Generous retirement offerings • Career development programs • Premium pay such as shift and on-call pay, based on eligibility • Incentive pay for select positions • Opportunity for annual performance-based increases • Paid Time Off programs • Medical, dental, vision, life, and short- and long-term disability benefits • Flexible Spending Accounts for eligible health care and dependent care expenses • Adoption assistance • Paid parental leave • Defined contribution retirement plans with employer match • Financial wellness programs • Educational Assistance Program